Identity
- Trade Name
- INTEGRA EUDAMED
- Device Name
- Balloon lnflation Device EUDAMED
- Model / Reference
- 111209 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906026862696 EUDAMED
- Basic UDI-DI
- 890602686BIDNA EUDAMED
- Direct Marketing DI
- 08906026862696 EUDAMED
- EMDN Code
- A03010199 INFUSION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Integra by Invent Bio-Med Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890602686BIDNA | Class I | Active |
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Manufacturer
- Manufacturer
- Invent Bio-Med Pvt Ltd
- EUDAMED SRN
- IN-MF-000028640
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (1)
- EUDAMED 5fe68e03-0464-4335-87ff-b3f6cd75c9d6 61 fields · synced Jun 19, 2026